| CTRI Number |
CTRI/2020/03/024119 [Registered on: 20/03/2020] Trial Registered Prospectively |
| Last Modified On: |
01/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of spinal morphine in reducing the requirement of locally anesthetizing drugs in labour analgesia |
|
Scientific Title of Study
|
Analgesic efficacy and Local anaesthetic sparing effect of intrathecal morphine as adjuvant to labor analgesia - A Double blinded prospective randomised controlled trial |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rushil Vladimir |
| Designation |
Junior resident |
| Affiliation |
AIIMS , New Delhi |
| Address |
Department of Anaesthesiology, Pain medicine and critical care room No- 5013, 5 Tth floor, teaching block, AIIMS, Ansari nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811461831 |
| Fax |
|
| Email |
rushilvladimir94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeshwari Subramaniam |
| Designation |
Professor |
| Affiliation |
AIIMS , New Delhi |
| Address |
Department of Anaestheisology, Pain medicine and critical care, Room no-5011, 5 th floor teaching block, AIIMS, Ansari Nagar, New Delhi-110029
South
DELHI
110029
India |
| Phone |
09868397810 |
| Fax |
|
| Email |
drsrajeshwari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rushil Vladimir R |
| Designation |
Junior resident |
| Affiliation |
AIIMS , New Delhi |
| Address |
Department of Anaestheisology, Pain medicine and critical care, Room no-5011, 5 th floor teaching block, AIIMS, Ansari Nagar, New Delhi..
South
DELHI
110029
India |
| Phone |
9811461831 |
| Fax |
|
| Email |
rushilvladimir94@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Ansari nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS ,
New Delhi - 110023 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrRushil Vladimir |
All India Institute if medical sciences |
Department of Anaestheisology, Pain medicine and critical care, Room no-5011, 5 th floor teaching block, AIIMS, Ansari Nagar, New Delhi-110029
New Delhi
DELHI |
9811461831
rushilvladimir94@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AIIMS ethics |
Approved |
| Ethics committee fo postgraduate research ,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnancy - labour pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group M -Intrathecal morphine |
Drug - Intrathecal morphine 250 mcgs + Bupivaciane 2 mg + Fentanyl 25 mcgs at the onset of labour pain followed by epidural catheterisation and epidiral analgesia will be provided till postnatal period of 24 hours. |
| Comparator Agent |
Intrathecal saline |
Drug - Intrathecal normal saline 0.25 ml + Bupivaciane 2 mg + Fentanyl 25 mcgs at the onset of labour pain followed by epidural catheterisation and epidural analgesia will be provided till postnatal period of 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA I and II
2.Primi gravida/ Mutigravida, para 0
3.Uncomplicated singleton pregnancy
4.Vertex presentation
5.Active labour
6.Requesting for labour analgesia
|
|
| ExclusionCriteria |
| Details |
- Local or systemic infection
- Patient not willing to participate
- Known allergy to study drugs
- Bleeding disorders
- Decreased platelet counts
- Usage of opioids/other analgesics in last 4hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of intrathecal morphine on Local anaesthetic requirement epidurally during labour |
Every 30 minutes till delivery, then every 6 hours postnatal till 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of intrathecal morphine on
1. Pain scores by VAS in I, II and III stages of labour
2.Incidence of maternal nausea and vomiting , urinary retention and pruritus
3.Rate of instrumental delivery
4.APGAR scores at 1 , 2 and 5 minutes
5. Maternal satisfaction (assessed by a subjective scale)
|
Every 30 minutes till delivery and then postnatal every 6 hours for 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A double blinded RCT on the analgesic efficacy and local anesthetic sapring effect of intrathecal morphine as adjunct for labour analgesia . Patients will be allocated to one of the two groups. Group M- Patients who will receive intrathecal morphine 250 μg along with bupivacaine 2 mg and fentanyl 25 μg Group F- Patients who will receive normal saline (0.25 ml) along with bupivacaine 2mg and fentanyl 25μg
|